US FDA's 'Program Alignment' Inspection Scheme Coming Mid-May; Details Still Murky

The agency's new inspectional approach – which will be structured along commodity-specific product lines – will be ready for primetime on May 15, the device center's compliance chief says.

Mark your calendar: US FDA investigators will begin inspecting device manufacturing facilities using the agency's brand-new "program alignment" inspectional approach on May 15.

That's according to Robin Newman, director of the Office of Compliance within FDA's Center for Devices and Radiological Health, who...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Compliance

Global Medtech Guidance Tracker: May 2025

 
• By 

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.

FDA Rebukes Four Companies, Including One Overseas, For Procedural Failures

 

The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.

Get Ready For International Harmonization Before Approaching QMSR Deadline, Says Regulatory Expert

 

During MD&M East last week, regulatory consultant Darren Reeves reminded device manufacturers that the time to get ready to comply with the new Quality Management System Regulation is now.

FDA Draft Guidance Introduces Electric Submission For Q-Sub Process

 

The US FDA says its updated draft guidance represents one of several steps the agency is taking to develop electronic submission templates for the medical device industry. The document introduces stakeholders to currently available resources for supporting their pre-subs to the agency.

More from Policy & Regulation

‘Dawn Of FDA’s AI Era’ Has Arrived. Makary Announces Early Implentation Of ‘Elsa’ Platform

 

US FDA Commissioner Marty Makary says the agency’s generative AI tool ‘Elsa’ will allow employees across the FDA to work more efficiently. The commissioner says Elsa’s launch comes ahead of schedule following a successful pilot program.

Medtech Experts Debate EU Recertification Gridlock

 

Modifying or doing away with the EU medtech recertification requirement is far from straightforward. Four experts from an EU national authority, an EU notified body trade association and industry, plus a well-known medtech consultant, reflect on how to move forward.

DeepLook AI Imaging Provides A Deeper Look At Dense Breast

 

DeepLook Medical recently announced the commercial rollout of DL Precise, an AI-powered imaging platform that enhances breast cancer screening, at major healthcare institutions across the US.